Johnson & Johnson, a leader in the pharmaceutical and biotech industry, is seeking an Analyst II EDC Data Acquisition Expert to join our Integrated Data Analytics and Reporting (IDAR) team in Mumbai, Bangalore, or Hyderabad. This role is pivotal in supporting our R&D portfolio by ensuring the successful setup and management of Electronic Data Capture (EDC) systems at the trial level. We pride ourselves on fostering innovation, collaboration, and professional growth within a dynamic environment.
Responsibilities in Job
As an Analyst II EDC Data Acquisition Expert, your key responsibilities will include:
- Planning and Execution: Oversee all data acquisition activities to ensure timely and quality deliverables in compliance with industry standards.
- Issue Management: Proactively manage and escalate issues, employing appropriate pathways to mitigate risks.
- Documentation and Standards: Contribute to the development and maintenance of departmental policies, procedures, and training materials.
- Vendor Management: Collaborate on functional vendor contracts, ensuring milestones and budgets are met.
- Continuous Improvement: Actively participate in initiatives aimed at enhancing EDC data acquisition capabilities and implement best practices.
- Regulatory Support: Ensure readiness for regulatory inspections related to data acquisition activities.
Qualifications
To qualify for this role, candidates must possess:
Required
- Education: A Bachelor’s degree in Clinical Data Management, Health, Computer Sciences, or a related field. Advanced degrees (Master’s or PhD) are preferred.
- Experience: Approximately 2 years in the pharmaceutical, CRO, or biotech industry, with a solid understanding of data management practices and regulatory guidelines (ICH-GCP, CDASH, SDTM).
- Technical Skills: Proven expertise in building and maintaining EDC systems like Medidata Rave, including integrations with CTMS, IWRS, and other data systems.
- Communication Skills: Strong verbal and written communication skills in English, with the ability to influence and lead cross-functional teams.
Preferred
- Innovative Mindset: Ability to think creatively in designing clinical development strategies.
- Familiarity with Data Technologies: Experience with EHR/EMR data, digital health technologies, and real-world data analytics.
Skills
Successful candidates will demonstrate:
- Project Management: Intermediate skills in managing projects and risks effectively.
- Collaboration: Established experience in working within a matrix environment, engaging with various stakeholders, vendors, and team members.
- Leadership: Strong decision-making capabilities, along with the ability to coach and mentor junior team members.
